Atopic dermatitis (atopic eczema) is a common skin condition that can have a big impact on the quality of life of both children and adults. I’ve been there, managing it for myself and for my children. We’ve been through wet wraps, preparations to put in the bath and to wash with; we’ve read about animals called Itchy and Scratchy who are supposed to make my child feel better about it all; and of course we’ve been through an awful lot of different creams. There are always two pressing questions, once you get onto medicated stuff, usually steroid creams – does it work and is it safe? Possible side effects, such as skin thinning, are quick to be mentioned.

Is there any evidence to back concerns about the safety of tacrolimus?

A possible alternative to the topical corticosteroids (TCS) which form the mainstay of treating atopic dermatitis is tacrolimus ointment which, along with pimecrolimus, is from a class of drugs called topical calcineurin inhibitors. It comes in two strengths, 0.1% and 0.03%. Newer than corticosteroids, it is important to know about its effectiveness and safety. Concerns have been raised about an increased risk of cancers such as skin cancer and lymphomas, based on the possible risk of absorption into the blood stream, but this is controversial, with no strong supporting evidence.

A Cochrane review has now been updated with the latest evidence from 20 randomized controlled trials with almost 6000 children and adults with moderate to severe atopic dermatitis, comparing topical tacrolimus with other active treatments. Previous research has shown that tacrolimus is better than placebo (a similar preparation without any drug). To find out as much as possible about side effects, the reviewers not only looked at data in the trials but also looked for other types of research, safety letters and industry warnings.

Here’s what they found:

Tacrolimus 0.1% was better than low-potency TCS on the face and neck and moderate-potency TCS on the trunk and extremities

Tacrolimus 0.03% more than doubled the chance of improvement compared with mild TCS or pimecrolimus 1%. In most trials, there was no difference between tacrolimus 0.03% and moderate strength TCS but in two studies TCS were slightly better

Side effects:

Burning and itching were more common with tacrolimus than TCS but symptoms were mild and short-lived

There was no difference in skin infection

Local (happening where applied) side effects were more common with tacrolimus than pimecrolimus and lasted longer: between 30 minutes and 12 hours compared with less than 30 minutes.

Serious side effects were rare in all groups and not thought to be related to treatment

It was rare to find the drug entering the bloodstream and only in diseases with severe skin barrier problems

No evidence was found to support the possible increased risk of skin thinning or cancer

How reliable is the evidence?

The evidence was of variable quality. The drugs, doses and outcomes varied between studies so it was not always possible to combine the results, which is done whenever possible in a systematic review. There’s good evidence that tacrolimus 0.1% is better than the milder 0.03% preparation and mild TCS. The evidence is less reliable when comparing both strengths of tacrolimus with moderate to potent TCS.

The research reported objective measures of improvement and doctor’s assessments of improvement but few reported patient’s self-assessments; shame!

The bottom line?

The reviewers say: “Tacrolimus ointment seems to be safe and effective for the treatment of moderate to severe atopic dermatitis in both children and adults.”

Looking ahead to more research on safety

Research was started in 2005 to assess the risk of cancers in children associated with topical tacrolimus ointment use, following a large cohort of children over ten years. The APPLES project will contribute valuable data on the long term safety of topical tacrolimus.

About Sarah Chapman

Sarah's work as a Knowledge Broker at Cochrane UK focuses on disseminating Cochrane evidence through social media, including Evidently Cochrane blogs, blogshots and the ‘Evidence for Everyday’ series for nurses, midwives, allied health professionals and patients.
A former registered general nurse, Sarah has a particular interest making evidence accessible and useful to practitioners and to others making decisions about health. Before joining Cochrane, Sarah also worked on systematic reviews for the University of Oxford and the Royal College of Nursing Institute, and obtained degrees in History from the University of Oxford and in the history of women’s health and illness in early modern England (MPhil., University of Reading).

Treating atopic dermatitis: tacrolimus seems to be effective and safe by Sarah Chapman

2 Comments on this post

Hi my name’s Scott i was using many steroid creams to treat mild exzema on my face , chest and behind ears for a few years and they stopped working and my face became reliant so i stopped using them. Was off the steroid creams for a month and face was itchy, sore, dry and red and i booked to see a skin specialist she gave me tacrolimus I’ve been using it for a week now and face is itchy and a little sore should i carry on or stop as i originally thought i had steroid withdrawal. Thanks

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